Disposable urea sensor and system for determining creatinine and urea nitrogen-to-creatinine ratio in a single device

a technology of urea nitrogen and creatinine, which is applied in the field of disposable electrochemical sensors, can solve the problems of high urea concentration in blood, malfunctioning kidneys will have difficulty in getting rid of excess urea, and the body is toxic to the extent of high urea concentration, and achieves the effect of fast response tim

Active Publication Date: 2007-06-14
NOVA BIOMEDICAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0016] It is an object of the present invention to provide a disposable urea sensor capable of measuring the urea concentration in a small volume of body fluid. It is another object of the present invention to provide a disposable urea sensor that is capable of measuring the urea concentration in a small volume of body fluid such as blood obtained by lancing the skin of the user. It is a further object of the present invention to provide a disposable urea sensor that has a fast response time. It is yet another object of the present invention to provide a disposable sensor for use in determining urea, creatinine and BUN-to-creatinine ratio in a body fluid sample. It is still another object of the present invention to provide a system for determining urea, creatinine and BUN-to-creatinine ratio in a blood sample with a single disposable device.

Problems solved by technology

High urea concentration in blood is toxic to the body.
Malfunctioning kidneys will have difficulty in getting rid of the excess urea.
None of the previous approaches, however, describes a combination of disposable, small volume, mass fabricated sensors with dissolvable reagent matrix containing the enzyme urease.
The prior known sensors have not enabled the desired point-of-care blood test for blood urea, thereby assuring that the procedure was complete.
On the other hand, a low BUN value may be caused by a diet very low in protein, malnutrition, or severe liver damage.
Drinking excessive amounts of liquid may cause overhydration and lead to a low BUN value.

Method used

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  • Disposable urea sensor and system for determining creatinine and urea nitrogen-to-creatinine ratio in a single device

Examples

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example 1

[0138] Demonstration of Determination of Urea Concentration with Ag-AgCl Reference

[0139] Blood samples with different urea concentrations were tested with the urea sensors of the present invention having a silver-silver chloride reference electrode and with the Vitros® Chemistry System DT6011 (Ortho-Clinical Diagnostics, Inc., Rochester, N.Y.). FIG. 14 shows the determination of BUN concentration in mg / dL in blood samples using the urea sensors of the present invention to varying urea concentrations in the blood samples. It is noted that these determinations are raw data before any compensation for hematocrit, in order to show the actual correlation of the unmanipulated data.

[0140] As seen from the graph, the sensors of the present invention respond to the urea concentration in the blood samples over a tested range of about 17 mg / dL to about 139 mg / dL of blood urea nitrogen. The average coefficient of variation for the sensors of the present invention using a silver / silver-chlorid...

example 2

[0141] Demonstration of Determination of Urea Concentration with Redox Reference

[0142] Blood samples with different urea concentrations were tested with the urea sensors of the present invention having a redox mediator / couple reference matrix and with a Dimension® Chemistry System (Dimension RxL, Dade Behring, Inc.). FIG. 15 shows the determination of BUN concentration in mg / dL in blood samples using the urea sensors of the present invention to varying urea concentrations in the blood samples.

[0143] As seen from the graph, the sensors of the present invention respond to the urea concentration in the blood samples over a tested range of about 19 mg / dL to about 187 mg / dL of blood urea nitrogen. The average coefficient of variation for the sensors of the present invention having a redox mediator / couple based reference is about 6.4%.

[0144] Note that the testing results can be corrected for hematocrit interference. The hematocrit of the blood sample can be calculated based on the impe...

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Abstract

A disposable urea sensor has a laminated body having a fluid sample inlet end and an electrical contact end, a fluid sample inlet, a substantially flat sample chamber in communication between the fluid sample inlet and a vent opening, the sample chamber being adapted to collect a fluid sample through the fluid sample inlet, a working electrode and a reference electrode within the sample chamber, and a reagent matrix disposed on the working electrode wherein the reagent matrix contains urease.

Description

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates generally to electrochemical sensors that can be used for the quantification of a specific component or analyte in a liquid sample. Particularly, the present invention relates to a disposable electrochemical sensor for measuring urea (or BUN, Blood Urea Nitrogen) in biological fluids such as blood. More particularly, the present invention relates to a system for simultaneously determining creatinine and BUN-to-creatinine ratio in a single device. Still more particularly, the present invention relates to a device that can be employed to perform assays of urea, creatinine and blood urea nitrogen-to-creatinine ratio in a small volume liquid sample (around 1 μL). [0003] 2. Description of the Prior Art [0004] In the liver, urea is synthesized from ammonia produced as a result of de-amination of amino acids. This biosynthetic pathway is the main means of disposal of excess nitrogen by the bod...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): G01N27/00
CPCG01N27/3271C12Q1/005
Inventor WINARTA, HANDANIPEI, JIANHONGLAURO, MARYYOUNG, CHUNG CHANGCAI, XIAOHUA
Owner NOVA BIOMEDICAL
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